PEM-oh-leenOral routeTabletTablet, Chewable
Because of its association with life-threatening hepatic failure, pemoline should not ordinarily be considered as first line drug therapy for Attention Deficit Hyperactivity Disorder (ADHD). Because pemoline provides an observable symptomatic benefit, patients who fail to show substantial clinical benefit within 3 weeks of completing dose titration, should be withdrawn from pemoline therapy.
Since pemoline's marketing in 1975, 15 cases of acute hepatic failure have been reported to the Food and Drug Administration (FDA). While the absolute number of reported cases is not large, the rate of reporting ranges from 4 to 17 times the rate expected in the general population. This estimate may be conservative because of under reporting and because the long latency between initiation of pemoline treatment and the occurrence of hepatic failure may limit recognition of the association. If only a portion of actual cases were recognized and reported, the risk could be substantially higher.
Of the 15 cases reported as of December 1998, 12 resulted in death or liver transplantation, usually within four weeks of the onset of signs and symptoms of liver failure. The earliest onset of hepatic abnormalities occurred six months after initiation of pemoline. Although some reports described dark urine and nonspecific prodromal symptoms (eg, anorexia, malaise, and gastrointestinal symptoms), in other reports it was not clear if any prodromal symptoms preceded the onset of jaundice.
Treatment with pemoline should be initiated only in individuals without liver disease and with normal baseline liver function tests. It is not clear if baseline and periodic liver function testing are predictive of these instances of acute liver failure; however it is generally believed that early detection of drug-induced hepatic injury along with immediate withdrawal of the suspect drug enhances the likelihood for recovery. Accordingly, the following liver monitoring program is recommended: Serum ALT (SGPT) levels should be determined at baseline, and every two weeks thereafter. If pemoline therapy is discontinued and then restarted, liver function test monitoring should be done at baseline and re-initiated at the frequency above.
Pemoline should be discontinued if serum ALT (SGPT) is increased to a clinically significant level, or any increase greater than or equal to 2 times the upper limit of normal, or if clinical signs and symptoms suggest liver failure.
The physician who elects to use pemoline should obtain written informed consent from the patient prior to initiation of pemoline therapy .
Pemoline has been associated with life-threatening hepatic failure and should not ordinarily be considered as first line drug therapy for Attention Deficit Hyperactivity Disorder (ADHD). Treatment should be initiated only in individuals without liver disease and with normal baseline liver function tests. Monitor serum ALT (SGPT) levels at baseline, and every 2 weeks thereafter. Discontinue if serum ALT (SGPT) is increased to a clinically significant level, or any increase greater than or equal to 2 times the upper limit of normal, or if clinical signs and symptoms suggest liver failure. Obtain written informed consent from the patient prior to initiation of therapy .
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Therapeutic Class: CNS Stimulant
Chemical Class: Amphetamine Related
Pemoline belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat children with attention-deficit hyperactivity disorder (ADHD).
Pemoline increases attention and decreases restlessness in children who are overactive, cannot concentrate for very long or are easily distracted, and are emotionally unstable. pemoline is used as part of a total treatment program that also includes social, educational, and psychological treatment.
Rarely, pemoline has caused serious liver problems. You and your doctor should talk about the good pemoline will do as well as the risks of using it. In addition, you will be asked to sign an informed consent form stating that you understand and agree to accept the risk of liver problems.
pemoline is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pemoline, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to pemoline or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Slowed growth rate in children who received medicines like pemoline for a long period of time has been reported. Some doctors recommend medicine-free periods during treatment with pemoline to help prevent slowed growth.
Pemoline may make behavior worse in children with serious mental illness.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of pemoline. Make sure you tell your doctor if you have any other medical problems, especially:
For patients taking the chewable tablet form of pemoline:
Sometimes pemoline must be taken for 3 to 4 weeks before improvement is noticed.
Take pemoline only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming.
The dose of pemoline will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pemoline. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of pemoline, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Your doctor should check your progress at regular visits to make sure that pemoline does not cause unwanted effects. In addition, you must have your blood tested every other week to see if pemoline is affecting your liver.
Dark urine or yellow eyes or skin may be a sign of a serious unwanted effect on your liver. Check with your doctor immediately if you develop dark urine or yellow eyes or skin.
pemoline may cause some people to become dizzy or less alert than they are normally. Make sure you know how you react to pemoline before you ride a bicycle or do anything else that could be dangerous if you are dizzy or are not alert.
If you have been using pemoline for a long time and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence on pemoline are:
If you take pemoline in large doses for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.
Along with its needed effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests.
Pemoline may cause some serious side effects, including liver problems. Also, medicines like pemoline, when used for a long time, have been reported to slow the growth rate of children. Some doctors recommend medicine-free periods during treatment with pemoline. Pemoline may also cause unwanted effects on behavior in children with severe mental illness.
Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:Rare
Check with your doctor as soon as possible if any of the following side effects occur:Rare
pemoline may also cause the following side effects that your doctor will watch for:Rare
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
After you stop using pemoline, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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